MARITIME-T2D-3

RecruitingPhase 3

Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes

A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes

Lead sponsor

Amgen

Assets

Maridebart cafraglutide / MariTide / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

1,300

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥25•HbA1c ≥7.5%

Primary endpoint

•Hemoglobin A1c (HbA1c)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07866066

Org study ID20230220

Secondary ID2025

Secondary ID2025-523772-22-00

Timeline

Milestones

Study first posted2026-10-08actual

Study start2026-10-16actual

Last update posted2026-11-05actual

Primary completion2028-09-06estimated

Study completion2028-12-05estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.

•Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.

•Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.

Exclusion criteria

•Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.

•Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

•Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.

•One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.

•History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

•Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.

•Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:

-liposuction and/or abdominoplasty that was performed > 1 year before screening.

-laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight at Week 68

Time frame:Baseline to Week 68

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68

Time frame:Baseline to Week 68

threshold achievement, improvement

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c at week 68 [Superiority]

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c < 7.0% at Week 68

Time frame:Week 68

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68

Time frame:Week 68

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c < 5.7% at Week 68

Time frame:Week 68

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose at Week 68

Time frame:Baseline to Week 68

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes

Time frame:Up To 81 Weeks

threshold achievement, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:Up To 81 Weeks

event count, event

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 68

Time frame:Week 68

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.